Swiss American CDMO · 3 weeks ago
Quality Assurance Engineer I
Carrollton, TX
Full-time
Onsite
Entry Level
2+ years expSwiss American CDMO is seeking a Quality Assurance Engineer I to coordinate and maintain Quality Assurance activities. The role involves supporting quality system activities, providing investigational support, and assisting with manufacturing problem-solving to meet customer requirements.
Consumer GoodsManufacturing
Responsibilities
Roles within this listing may be “shadow” roles coached by experienced QA Engineers until proficiency is demonstrated
Capable of providing Quality Assurance support and expertise for 1-3 clients, prospects and/or leads
Create and execute problem-solving and process improvement initiatives with manufacturing, CPMs/PMs and customers to eliminate or reduce issues or failures
Analyze and appropriately prioritize demands, task assignments, investigation activities, risk factors, and data analysis to meet Site Objectives, Customer requirements and Quality/Compliance initiatives
Assist with CAPA Coordination activities, i.e. Corrective and Preventive Actions, implementation plans, CAPA meetings, etc
Assist with bi-annual reviews of Standard Operating Procedures (SOPs), including their creation, revision, and approval to ensure accuracy, relevance, and compliance
Support the Validation activities with execution and documentation as needed
Initiate, Write, Author, Review and Manage Quality Documentation as needed i.e. Non-Conformance Reports (NCR), Rework Plans, Risk Assessments, Validation Protocols, and other applicable documents and routing via the QMS software
Effectively utilize several root cause analyses, data analysis and problem-solving techniques such as 6M, Fishbone, Is/Is Not, 5WHYs, Statistical analysis with Qualitative and Quantitative data (variable and attribute data sets), Process Control Charts, Standard Deviation, Statistical Sampling Plans and AQL criteria as well as risk assessment methodologies etc
Work effectively with site functions to develop and implement specifications and execute change control/request deliverables
Effectively utilize SWISS & MS Office software (uniPoint, Deacom, Laserfiche, Excel, Word, Pivot Tables, Power Point, Project Management tools) to collect and analyze data (electronic and manual), create charts and trend reports, create power point presentations on performance as well as effectively present the data analysis
Other duties may be assigned by the Manager
Qualification
Required
Minimum of 2 years of experience in a manufacturing environment
Excellent written and verbal communication skills
Ability to effectively communicate technical information to various audiences (managers, clients, regulatory agencies)
Ability to write clear, concise reports, procedures, and technical documentation
Strong analytical and problem-solving skills with a focus on data analysis
Proficiency in statistical concepts, including probability, frequency distributions, and control charting
Familiarity with risk assessment methodologies
Ability to analyze complex data, identify trends, and draw valid conclusions
Strong problem-solving and decision-making skills
Ability to interpret and apply various instructions and regulations
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
Experience with Quality Management Systems (QMS) software
Ability to generate charts, trends, and presentations effectively
Preferred
Bachelor's degree in Science, Engineering, or a related field preferred
Company
Swiss American CDMO
Swiss American CDMO is a developer and manufacturer of topical skin and wound care products.
201-500 employees
H1B Sponsorship
Swiss American CDMO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
Funding
Current Stage
Growth StageLeadership Team
Komel Grover
President & CEO
Company data provided by crunchbase